Progress on FSMA, Changes within the FDA Foods Program, and on Partnerships

As prepared for delivery by Michael R. TaylorDeputy Commissioner for FoodsU.S. Food and Drug Administration

It’s a pleasure to participate in the 2012 Science Writer’s Symposium to talk about food safety.

The food safety arena is in an extraordinarily dynamic phase – at FDA and across the global food system. Change is underway, and it is change that is grounded in our scientific understanding of foodborne illness, its causes, and how it can be prevented. It is thus fitting at this Science Writers Symposium to review where we are in implementing the FDA Food Safety Modernization Act (FSMA) and the science-based, public health prevention vision on which it is based, including the critical role science will continue to play.

My central message is this: FDA eagerly embraces change in its food safety program and is hard at work laying the foundation for a modern, prevention-oriented food safety system that works better for consumers and the food industry. Much has been done, but much remains to be done, both by FDA and the industry it regulates, working in collaboration to reduce foodborne illness.

Some of the change we’re pursuing is directly called for by FSMA, while other changes are being initiated by FDA in how we work internally and with our stakeholders to achieve the modern food safety system envisioned by FSMA. Today, I would like to talk about change on all three fronts, including the significant progress we’ve made on specific FSMA mandates, the changes we are making within FDA to do our job better under FSMA, and how we are working in new ways with industry, consumer groups and our counterparts at the state and local levels. I want to begin, however, with the vision represented by FSMA, because it is so fundamental to answering the question of “why” we are doing all of this work.

The FSMA Vision and Mandate

The vision underlying FSMA is by now familiar. It begins with the widely shared understanding that the current burden of foodborne illness in the United States is unacceptable. The CDC estimates of 3,000 deaths, 128,000 hospitalizations and 48 million illnesses associated annually with foodborne pathogens state the public health burden in stark quantitative terms. They do not do justice, however, to the toll on families that lose a child, parent, or grandparent. And they do not capture the loss of confidence in the safety of food caused by illness outbreaks and major contamination incidents – a loss of confidence that can steer consumers away from healthy foods, like fresh fruits and vegetables, and impose big economic losses on food producers and processors.

The significant public health and economic impacts of foodborne illness are what brought the food industry and consumers together with congressional leaders to enact FSMA. This convergence was based not only on a common understanding of the food safety problem but also a remarkable consensus on the solution – a solution born out of food industry experience grappling with food safety challenges in today’s complex global food system. We know that pathogens can enter the food supply at any stage along the pathway from the farm through processing, transport, storage and retail sale. We also know that reasonable, science-based steps can be taken at each stage to prevent and minimize the presence and growth of pathogens and thus reduce the risk of illness.

Thus, stated in the simplest terms, the recognized solution to the problem of foodborne illness is a comprehensive prevention strategy that involves all participants in the food system, domestic and foreign, doing their part to minimize the likelihood of harmful contamination. And that is the strategy mandated by FSMA. It is not a strategy that assumes we can achieve a zero-risk food supply, but it is a strategy grounded in the conviction that we can better protect consumers and the economic vigor of the food system if everyone involved implements reasonably available measures to reduce risk.

The FSMA strategy recognizes that the food industry has the primary responsibility and capacity to produce safe food, but it calls for a new definition of public and private roles on food safety and a modern new framework for regulatory oversight, integration of government food safety efforts, and public-private collaboration.

Promulgation by FDA of standards for implementation of such preventive measures by produce growers, food processing and storage facilities, and food transporters.

New administrative enforcement tools and a mandate to partner with state and local officials to oversee and ensure compliance with prevention-oriented standards by U.S.-based operators.

An expectation that imported food be as safe as domestic food and a mandate for FDA to build a new import system, beginning with a new requirement for importers to verify that their foreign suppliers are implementing modern preventive measures comparable to the ones FSMA requires of U.S. firms.

An expectation that FDA will target its FSMA implementation efforts and ongoing oversight in a manner that takes account of risk and opportunities to reduce risk and that makes optimal use of both public and private resources to improve food safety.

Though many in the private sector are already implementing modern preventive measures, implementing the FSMA strategy will require varying degrees of change in private sector practices and a real transformation in how FDA does its job. FDA also knows that its rules and oversight practices must take full account of the diversity of operations covered by FSMA, be risk-based and flexible, address small business issues, and be backed up by guidance, technical assistance, educational outreach and other collaborative efforts to support private sector implementation of FSMA’s new prevention paradigm.

FDA’s commitment to the FSMA vision and strategy is unwavering, as is our commitment to building the modern food safety system envisioned by FSMA in close collaboration with the industry and consumer stakeholders who worked hard to enact our new food safety law. Fully implementing the sweeping change called for by FSMA will take years, but I am proud of the work that we and our stakeholders have done in the 19 months since enactment to lay the foundation for a modern, prevention-oriented food safety system. So let me begin with what we have accomplished under FSMA.

FSMA directs FDA to complete some 90 specific deliverables over the several years following enactment, including a host of regulations, guidance documents for industry, notices, studies, reports to Congress, and pilot projects. While FDA lacks the resources to do everything at once, we have worked hard to prioritize our efforts and to deliver on both immediate and longer term FSMA mandates. Our accomplishments are documented at www.fda.gov/fsma, and some of our accomplishments in the 19 months since enactment include:

Three final rules published in the Federal Register;

Nine draft and final guidance documents published in the Federal Register with two more in clearance;

Five reports to Congress completed and submitted;

Notices published on state and local food defense capacity and implementation of FSMA re-inspection fees;

Anti-smuggling strategy published jointly with the Department of Homeland Security.

Product tracing pilot studies carried out;

Memorandum of Understanding signed with the U.S. Department of Agriculture to establish a FSMA implementation grant program for small-scale produce growers.

In addition, FDA has made very substantial progress on other major FSMA deliverables, including:

Four major framework proposed rules and accompanying regulatory impact analyses under review at the Office of Management and Budget, covering preventive control standards for human and animal food facilities, produce safety standards, and foreign supplier verification requirements for importers;

Proposed rules establishing the accredited third party certification program and transport safety standards close to completion within FDA;

An advance notice of proposed rulemaking on intentional adulteration drafted and close to completion within FDA.

When these rules are in place, they will play a major role in transforming the food safety system.

In addition to these matters, substantial work is underway within FDA on dozens of other specific FSMA deliverables.

As important as the specific FSMA deliverables are to construction of the new food safety system, the success of implementation depends equally on FDA developing transformative new strategies for how it will work internally and with its partners to achieve FSMA’s prevention goal. Teams of FDA managers and experts have made substantial progress and continue to work on strategy and system building in the following key areas, among others:

Inspection and Compliance Strategy

Traditionally, FDA’s food safety inspections have focused largely on making observations in food facilities that might indicate a violation of statutory adulteration provisions and collecting evidence to support possible judicial enforcement action. This has enabled FDA to remedy observed food safety problems, such as insanitation or product contamination. Under FSMA, FDA inspectors will still be able to observe and document such violations, but, with FSMA’s new preventive control requirements and administrative enforcement tools (such as product detention and facility suspension), they will be able to assess whether facilities have in place the proper systems and controls to prevent problems, and take much more immediate corrective action to protect public health when facilities don’t have these in place.

FDA is actively planning how it will implement this paradigm shift from a reaction focus to a prevention focus, which we know will require major change in how FDA conducts food safety inspection and compliance activities, including:

Better targeting of inspections and adjustment of inspection practices based on inherent risk and past performance;

New techniques for conducting system-oriented inspections, including strong technical support for in-plant inspectors;

Streamlined procedures for making public health decisions during inspections, obtaining immediate voluntary corrections, and using administrative enforcement tools when appropriate;

Working more closely with state and local government partners on inspections and follow up actions to protect consumers.

Risk-Based Priority Setting and Resource Allocation

As part of system building to support FSMA implementation, FDA has launched a major effort to enhance risk-based priority setting and resource allocation across its entire food and veterinary medicine program. This is good policy any time, but it is essential at this time of scarce resources to be able to demonstrate that we are getting the most public health bang for our buck. Moreover, the mandate to set risk-based priorities and standards pervades FSMA, including its provisions on preventive controls in food facilities, produce safety standards, domestic inspection frequency, and import oversight.

FSMA specifically requires FDA to identify “the most significant foodborne hazards” and take action to address them. We have a team developing this list through an open, transparent process, and we expect the results will influence priority setting and resource allocation in almost all of our food safety activities, including research planning, development of future standards and guidelines for industry, and targeting of food surveillance and facility inspection. We also have teams working to identify and build the analytical tools, decision processes and data collection we will need for a robust and data-driven system of risk-based priority setting and resource allocation for all of our food and veterinary medicine programs.

New Import Safety System

FDA’s past oversight of food imports has been limited largely to screening and targeted examination of import shipments at the port of entry. FDA has made good use of its limited legal tools and resources to address import safety issues, but FDA lacks the tools and resources to keep up with the flood of food imports, which have roughly doubled over the last decade, from about 4.4 million entries in fiscal year 2002 to about 8.6 million entries in the current fiscal year. FSMA addresses this problem by giving FDA a multi-faceted tool kit to shift the paradigm for imports, just as for domestic food, from a strategy of reaction to one of systematic prevention. Thus, rather than rely primarily on FDA’s port inspectors to detect and respond to safety problems, FSMA commands importers to verify they have systems in place to prevent unsafe food from entering the country and gives FDA the authority and mandate to audit the adequacy of those systems, accredit reliable private auditors to back up government oversight, expedite entry of qualified importers with good performance records, conduct more foreign inspections, and work more closely with foreign governments to strengthen assurances of safety and avoid duplication of effort.

Since enactment of FSMA, FDA has been working internally and in dialogue with stakeholders on how to make good use of these tools, which means not just issuing new rules but creating an integrated new import oversight system that works efficiently to improve food safety without unduly impeding trade.

Science and Research

Needless to say, moving forward on all of these FSMA implementation fronts requires a solid science and research foundation. Science is the essential foundation, the critical underpinning, of everything we do to protect public health. It supports the standards we set, our ability to evaluate the safety of food, and our ability to minimize hazards and prevent harm. We invest significant resources to maintain and build our scientific foundation. We could not meet the public’s food safety expectations without this investment.

FSMA only increases our science and research needs. We are being called on to develop standards for the safe production of produce and for the implementation of preventive controls across the many diverse sectors of the food supply. We are being called on to base our activities, including inspections, on risk. We are being called on to identify the most significant contaminants.

These demands, coupled with the changing nature of the food supply and the risks it poses, magnify our scientific challenges. We are seeing a dizzying array of new foods in the marketplace, many produced using new technologies. We are seeing new pathogens emerge as well as “not so new” pathogens in foods where we never expected them to be. We are seeing an increase in the percentage of the population that is particularly “at risk” for foodborne illness – including the elderly, pregnant women, and immune compromised individuals.

These developments challenge us to move forward strategically in planning and executing our food safety research program. We must be sure that the research we do to understand hazards and interventions and develop analytical methods contributes directly to fulfilling our mission. Our Center for Food Safety and Applied Nutrition (CFSAN) and Center for Veterinary Medicine (CVM) have been working to prioritize their food safety research, and today, you heard about two of our ongoing research projects – one on Salmonella in tomato production and the other on rapid methods for detecting Salmonella in animal feed and pet food. These are the kinds of mission-critical research that FDA needs to do.

To make sure our overall research agenda is directly responsive to clearly identified program needs and well-prioritized, we recently created the position of Chief Science Officer and Research Director. Since May, Dr. David White, who is CVM’s research director, has been acting in that position and as chair of our Science and Research Steering Committee, which is comprised of science and research leaders from CFSAN, CVM and FDA’s Office of Regulatory Affairs (ORA) and National Center for Toxicological Research. I have charged the committee with:

Developing a program-wide process for prioritizing our research in alignment with our public health mission and regulatory priorities and linking research priorities with budget planning and execution;

Improving how we transfer technology and the fruits of our research to our program offices;

Identifying and investing in disciplines and specialties that are critical to carrying out our program.

This is a big job because it is a never-ending job. Our regulatory priorities will change as new hazards emerge. New food technologies mean that the knowledge needed to ensure the safety of these new types of foods must keep pace. So the process of ensuring that our science and research agenda mirrors our public health and regulatory priorities will be a continual process.

Outbreak Response

Outbreak response is another significant area of change within FDA, and we are already seeing improvements as a result of the launch one year ago of the Coordinated Outbreak Response and Evaluation (CORE) network. Next on the agenda is a presentation on one of the outbreaks CORE responded to.

CORE is a streamlined approach to managing FDA’s foodborne outreach surveillance, response and post-response efforts. Previously, a lot of talented, hard-working individuals were pulled together when an outbreak occurred; they worked diligently to solve the problem and then they went back to their day jobs. This approach did not lend itself to the sustained, focused efforts needed within FDA.

We now have a full-time, multidisciplinary team of experts under the leadership of our Chief Medical Officer—Dr. Kathleen Gensheimer. The CORE Network is working with our federal, state and local partners in all phases of the effort. These include new ways of picking up signals earlier, using every mechanism possible to help inform epidemiological investigations so that the identification of a specific vehicle can be accomplished as quickly as possible, planning and training for quick response, designing and implementing in-depth root cause investigations when appropriate, rapid communication of findings, and ensuring that the findings are used to help reduce the risk of future outbreaks.

These are just some of the new strategies and systems called for by FSMA to modernize the food safety system. FDA has also invested significant effort since enactment and made real progress in such areas as planning a private laboratory accreditation system to improve the reliability of private lab results, developing guidance documents and a proposed rule to implement FSMA’s new facility registration system, and completing a web-based search function for food recalls.

FDA’s system building efforts under FSMA do not often receive much public attention, but they are essential to laying the foundation for successful implementation of FSMA.

We have known from the start that we cannot implement FSMA on our own. Thus, new ways to work with external stakeholders and partners is a central theme of our work.

Public Engagement and Partnership

FDA has invested heavily in public engagement to gain input on many aspects of FSMA implementation, including the major FSMA preventive control rules that are under development, how inspection and compliance should work under FSMA, and the new import oversight system. We started out, even before FSMA was enacted, by touring 14 states to visit farms of all sizes and types. We also visited food processing facilities and pet food establishments. This on-the-ground interaction with growers and manufacturers allowed us to listen to their ideas first hand, providing a real-world, common-sense understanding as we began developing the FSMA rules.

We also opened two dozen dockets for written public comment on key issues and convened five formal public meetings. We participated in several hundred presentations, individual meetings, webinars, and teleconferences with industry and consumer groups and partners in other federal and state agencies. The input and dialogue this outreach has made possible will improve every aspect of how FDA implements FSMA from policy design through rulemaking and on-the- ground implementation.

One critical area of FSMA implementation demanding both public input and real operational partnership concerns educational outreach and technical assistance to support implementation of new preventive measures by small and medium-size firms. To that end, even before we have finalized new requirements, we have established three alliances, or public-private partnerships, to develop training materials and create a technical assistance network to help industry comply with FSMA requirements. The Food Safety Preventive Controls Alliance and the Sprouts Safety Alliance are being coordinated by the Illinois Institute of Technology. The Produce Safety Alliance is being coordinated by Cornell University. All three alliances bring together FDA, local and state food protection agencies, the food industry, and academia to determine what will work best to help prepare firms to implement FSMA.

Federal-State Integration

FDA has long collaborated with state and local food safety agencies on inspection, laboratory analysis, retail food safety and response to outbreaks. In FSMA, however, Congress makes it a statutory mandate for FDA to go well beyond current collaboration and build an integrated national food safety system that makes the best use of all available public resources to implement FSMA’s prevention model.

This will include joint planning of inspections to improve targeting and efficiency, expanded reliance on state inspections conducted in accordance with FDA standards, mutual reliance on inspection results and laboratory analyses, and strengthened collaboration in responding to outbreaks and major contamination incidents.

Since enactment of FSMA, FDA has been working to enhance its partnership with the states in all these areas and others through a set of committees and work groups known as the Partnership for Food Protection. We also commissioned a joint FDA-state-local task force to examine and make recommendations for steps FDA could take to remove obstacles to seamless integration of federal, state and local food safety activities. In August, we brought our state and local partners together from across the country to hear some of the task force recommendations, assess progress, work on critical issues, and plan for the future.

FDA has invested enormous effort and made great progress in implementing the Food Safety Modernization Act. We are laying the policy, program and scientific foundation for a food safety system that will work better for consumers and the food industry. I am grateful for the extraordinary commitment, resilience and skill of the many people all across FDA who are working on FSMA implementation. I am also grateful for the active and positive engagement of our consumer and industry stakeholders.

We are all fortunate to be working on food safety at this time of great challenge and historic opportunity to build a modern new system that will benefit all for years to come. It’s a long-term process. We have to stick with it. But we have real momentum, and I work with confidence that we’ll succeed in the great task Congress has given us.